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AO Multicenter Intervention Trial for Prevention of Surgical Site Infection (AOPOSSI)

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ClinicalTrials.gov Identifier: NCT03380273
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:

This study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. The intervention consists on the implementation of the AOT SSI Prevention Bundle.

D


Condition or disease Intervention/treatment Phase
Surgical Site Infection Behavioral: Implementation of the AO Trauma SSI Prevention Bundle Not Applicable

Detailed Description:
During the first phase of the study, 4,238 patients will be recruited and the baseline incidence of surgical site infection at each participating site will be determined. At the beginning of the third year, the bundle will be implemented and data on 4,238 additional patients will be collected. The incidence rate on surgical site infection before and after the intervention will be compared. We hypothesize that this intervention will reduce the infection rate within the first 3 months after surgery from 6% to 4.5% (5% to 3.75% in closed fractures and from 10% to 7.5% in open fractures).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8476 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: During two years, patients with fractures are recorded and the occurence of surgical site infections (SSI) in these patients is monitored in different sites over the world. After two years, a bundle of known prevention measures are teached and enforced in these sites. Then the occurence of SSI in fracture patients is monitored for another two years to see whether the bundle decreased the SSI occurence.
Masking: None (Open Label)
Masking Description: It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.
Primary Purpose: Prevention
Official Title: AO Multicenter Intervention Trial to Evaluate the Impact of a Bundle of Measures for the Prevention of Surgical Site Infection in Fracture Patients
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
No Intervention: pre-intervention
The number of SSI are collected in this phase. Patients with fractures are enrolled and their standard of care treatment is observed.
post-intervention
Here the same observations are made as in the first arm, however this is after the hospital staff was thought the prevention measures (all by themselves approved) and enforced to be applied.
Behavioral: Implementation of the AO Trauma SSI Prevention Bundle

AOT SSI Prevention Bundle

Preventive measure

  1. Antibiotic prophylaxis
  2. Perioperative antibiotics
  3. Oxygen administration
  4. Patient temperature
  5. Surgeon protective wear
  6. Patient operative skin preparation
  7. Suction drains
  8. Blood glucose level
  9. Red cell transfusion
  10. Dressing changes




Primary Outcome Measures :
  1. Infection Rate [ Time Frame: within 3 months after surgery ]
    Surgical site infection rate as defined by CDC or FRI definition


Secondary Outcome Measures :
  1. Implementation success of the AOT SSI Prevention Bundle [ Time Frame: up to 48 months ]
    Compliance rate for each measure of the bundle before and after the intervention

  2. Evaluation of attitudes, perception and knowledge concerning SSI [ Time Frame: up to 48 months ]
    Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle

  3. Surgeon satisfaction [ Time Frame: up to 48 months ]
    Cross sectional survey of opinion concerning user friendliness of the AOT SSI Prevention Bundle, value of the educational intervention and intention to adopt the AOT SSI Prevention Bundle long term before and after its implementation

  4. Health-economic analysis [ Time Frame: up to 48 months ]
    The clinical effectiveness of the implementation of the AOT SSI Prevention Bundle and consecutively the costs saved by preventing infections and its treatment is compared against the costs which have to be invested in order to implement the AOT SSI Prevention Bundle (e.g. costs generated by development of teaching material, time needed to teach/implement the intervention, extra material needed according to the interventions etc.).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Age > 18 years

    • Recent fracture (< 10 days) located in femur, tibia or humerus

      • Any type of open or closed fracture
      • Produced by high or low energy trauma
    • Primary fracture treatment with surgery and use of any of the following:

      • Intramedullary or extramedullary devices including cases in which a temporary external fixator is used
      • Joint replacement
    • Informed consent obtained (if required by local EC/IRB), i.e.:

      • Ability to understand the content of the patient information/ICF
      • Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
      • Signed and dated EC/IRB approved written informed consent

Exclusion Criteria:

  • Pathologic fracture secondary to tumors, infection or cysts
  • Patients with an underlying chronic, bone and joint infection or prior history of a bone and joint infection
  • Refracture and non-union
  • Peri-implant fractures
  • Patients with terminal illness
  • Pregnancy or women planning to conceive within the study period
  • Prisoner
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380273


Contacts
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Contact: Claudia Zimmerli, PhD +792638487 claudia.zimmerli@aofoundation.org
Contact: Severine Hurni, PhD +41814142509 severine.hurni@aofoundation.org

Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
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Principal Investigator: Stephen Kates, MD VCU Health

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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT03380273     History of Changes
Other Study ID Numbers: 113161
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share the individual participant data. The analyses will be done based on groups and these data will be published and shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes